MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT®; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 24321

Device Problems Fluid/Blood Leak (1250); Retraction Problem (1536)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/09/2019

Event Type  malfunction  

Event Description

Have had multiple issues regarding the vanishpoint blood collection set 23g and 25g.Needle did not retract into chamber and left exposed needle out for possible injury.Kept needle to view."flash" was never given when in vein and almost caused patient to be recollected, 3 different patients today.Blood leaked out around needle (chamber area) and all over counter and gloved hands.Needle easily comes apart and fear exposure.Manufacturer response for greiner vanishpoint, greiner vanishpoint (per site reporter).Conference call friday (b)(6), clinical rep here on site yesterday afternoon to do observations of staff practice while using the device.

• Brand Name: VANISHPOINT®
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 8635529
• MDR Text Key: 145913515
• Report Number: 8635529
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 24321
• Device Catalogue Number: 24321
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1